(14 days)
As a consistent test sample of known concentration for monitoring the performance of ASO, CRP, and RF immunoturbidimetric assays.
The KAMIYA ASO/CRP/RF Control is a lyophilized, human serum-based, assayed control for use as a consistent test sample of known concentration for monitoring the performance of ASO, CRP, and RF immunoturbidimetric assays. Two levels of the KAMIYA ASO/CRP/RF Control are provided. The human serum used to manufacture this product is tested and found negative for the presence of HBsAg and antibody to HCV and HIV. The assigned CRP values are traceable to the CAP/BCR/IFCC Reference Preparation for Proteins in Human Serum. The assigned RF values are traceable to the WHO International Reference Preparation of Rheumatoid Arthritis Serum. The assigned ASO values are traceable to the Japanese National Standard for ASO. This product is stable for at least 1 year (unopened) and 2 weeks (after reconstitution).
The provided text describes the Kamiya ASO/CRP/RF Control, a lyophilized human serum-based control product used to monitor the performance of ASO, CRP, and RF immunoturbidimetric assays. The document is a 510(k) summary, which indicates that the device has been cleared by the FDA based on its substantial equivalence to a legally marketed predicate device.
1. Table of acceptance criteria and the reported device performance:
The document states that the safety and effectiveness of the KAMIYA ASO/CRP/RF Control is demonstrated by its substantial equivalence to the Sigma Immunology Control (K851202).
| Acceptance Criteria Category | Specific Criteria/Measurement | Reported Device Performance (KAMIYA ASO/CRP/RF Control) |
|---|---|---|
| Substantial Equivalence | Equivalence to predicate device Sigma Immunology Control (K851202) | Demonstrated |
| Precision | Similar within-run precision | Achieved |
| Precision | Similar between-day precision | Achieved |
| Reaction Characteristics | Similar reaction characteristics for ASO, CRP, and RF analytes | Achieved |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample size used for the test set. It mentions "within run and between day precision," implying that multiple measurements were taken over different runs and days, but the number of samples or runs is not quantified. The data provenance is not specified (e.g., country of origin). The study appears to be a prospective validation conducted by the manufacturer to demonstrate equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to this type of device. The ground truth for this control product is its assigned values, which are traceable to specific international or national reference materials (CAP/BCR/IFCC Reference Preparation for Proteins in Human Serum for CRP, WHO International Reference Preparation of Rheumatoid Arthritis Serum for RF, and Japanese National Standard for ASO for ASO). These are not established by human experts in the context of image or signal interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. This is not a study involving human interpretation or adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a quality control product for laboratory assays, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device itself is a control material, not an algorithm. The study implicitly evaluates the standalone performance of the control material in terms of its precision and reaction characteristics when used with immunoturbidimetric assays, by comparing it to a predicate device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the assigned values of the control product is established through traceability to international and national reference standards:
- CRP: CAP/BCR/IFCC Reference Preparation for Proteins in Human Serum
- RF: WHO International Reference Preparation of Rheumatoid Arthritis Serum
- ASO: Japanese National Standard for ASO
8. The sample size for the training set:
Not applicable. This device is a control product, not an algorithm that requires a training set. The values are assigned based on reference materials, not derived from a machine learning model.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device. The "ground truth" for the control's values is established by its traceability to recognized international and national reference preparations/standards as described in point 7.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.